Beruflich Dokumente
Kultur Dokumente
No. 10-5287
v.
2
Jon E. Pettibone, Neal Goldfarb, and Andrew T. Karron
were on the brief for amici curiae State of Wisconsin, et al. in
support of appellants.
3
an embryo, it does not prohibit funding a research project in
which an ESC will be used. We therefore vacate the
preliminary injunction.
I. Background
4
by one or another of several research universities, which make
them available for scientific use, usually for a small fee.
5
of ESCs, which they made available to investigators who
might apply for NIH funding.
6
human embryos is prohibited by ... the Dickey-Wicker
Amendment.” Id. at 32,175/2. The Guidelines further
addressed Dickey-Wicker as follows:
Id. at 32,173/2.
7
stem cell lines derived from an embryo donated after the
effective date of the Guidelines only if the in vitro clinic had
fully informed the donor of all possible options for disposing
of the embryo and had taken other specified procedural steps
to separate reproductive treatment from donation. Id.
II. Analysis
9
of irreparable harm, among other things.” Id. at 1296. They
noted that the Winter Court seemed to treat the four factors as
independent requirements and specifically to reject the Ninth
Circuit’s statement that a strong likelihood of success on the
merits lessens the movant’s burden to showing merely a
“possibility” rather than a “likelihood” of irreparable harm.
Id. (citing Winter, 129 S. Ct. at 374-76); see also Nken v.
Holder, 129 S. Ct. 1749, 1763 (2009) (Kennedy, J.,
concurring) (“When considering success on the merits and
irreparable harm, courts cannot dispense with the required
showing of one simply because there is a strong likelihood of
the other”).
10
USDA, 573 F.3d 815, 821 (D.C. Cir. 2009). In this case, our
de novo review is central to the plaintiffs’ likelihood of
success on the merits, see City of Las Vegas v. Lujan, 891
F.2d 927, 931–32 (D.C. Cir. 1989), which success depends
upon an issue of statutory interpretation.
11
destroyed in order to yield an ESC, any later research project
that uses an ESC is necessarily “research” in which the
embryo is destroyed. For its part, the Government argues the
“text is in no way an unambiguous ban on research using
embryonic stem cells” because Dickey-Wicker is written in
the present tense, addressing research “in which” embryos
“are” destroyed, not research “for which” embryos “were
destroyed.”
*
The plaintiffs urge us to adopt the district court’s view that
Dickey-Wicker incorporates the definition of “research” in the
Human Subject Protection regulations: “a systematic investigation,
including research development, testing and evaluation, designed to
develop or contribute to generalizable knowledge.” 45 C.F.R. §
46.102(d). The Government argues otherwise, but we need not
resolve this debate because, as the Government also argues, that a
project involves “research development” or is “‘systematic’ does
not mean that it includes acts or processes,” such as deriving ESCs,
“that predated the federally funded research.”
Case: 10-5287 Document: 1305585 Filed: 04/29/2011 Page: 12
12
The plaintiffs respond by reiterating their primary
argument: Because “research” using an ESC includes
derivation of the ESC, the derivation does not predate but is
an integral part of the “research.” The conclusion does not
follow from the premise; at best it shows Dickey-Wicker is
open to more than one possible reading. * The plaintiffs also
argue we must read the term “research” broadly because the
Congress, had it intended a narrower reading, would have
used a term identifying a particular action, as it did in
subsection (1) of Dickey-Wicker, which specifically bars the
“creation” of an embryo for “research purposes.” We see no
basis for that inference. The definition of research is flexible
enough to describe either a discrete project or an extended
process, but this flexibility only reinforces our conclusion that
the text is ambiguous.
*
The plaintiffs rely upon Merck KGaA v. Integra Lifesciences I,
Ltd., 545 U.S. 193, 202 (2005), but that case is inapposite; it
involved a statute that protected from an infringement claim the use
of patented materials “reasonably related to the development and
submission of information” to the FDA in a regulatory proceeding.
Although the Court concluded the statute protected the use of
patented materials at all phases of research, the ruling did not
depend upon an interpretation of the term “research,” and does not
bear upon our understanding of “research” in Dickey-Wicker. See
id. at 202.
Case: 10-5287 Document: 1305585 Filed: 04/29/2011 Page: 13
13
is not an “embryo” and cannot develop into a human being.
The plaintiffs do not dispute this much of the agency’s
reasoning.
14
in which an embryo is destroyed. See Nat’l R.R. Passenger
Corp. v. Boston & Maine Corp., 503 U.S. 407, 420 (1992)
(that agency’s “interpretation of the word ‘required’” was
implicit “does not mean that we may not defer to that
interpretation”).
15
Government pointed out at oral argument that “stem cells are
not pre-labeled cells that you can simply extract,” and argued
“the scientific process” of derivation, in which cells are
“extracted and put into mediums where [they] can grow”
before being examined and chemically treated, “itself
involves experimentation.”
16
reading. Because the Congress wrote with particularity and in
the present tense — the statute says “in which” and “are”
rather than “for which” and “were” — it is entirely reasonable
for the NIH to understand Dickey-Wicker as permitting
funding for research using cell lines derived without federal
funding, even as it bars funding for the derivation of
additional lines.
*
The parties’ disagreement over whether the NIH’s interpretation
should be deemed “longstanding” is beside the point; this is not a
situation in which we are asked to infer the Congress’s assent from
Case: 10-5287 Document: 1305585 Filed: 04/29/2011 Page: 17
17
3. Subsidiary Arguments
its inaction over a long period. Regardless how much time has
passed, reenactment is evidence the Congress approves the
agency’s application of the statute. Creekstone Farms Premium
Beef L.L.C. v. USDA, 539 F.3d 492, 500–501 & n.10 (D.C. Cir.
2008).
*
The same is true of the plaintiffs’ suggestion that a researcher
might use federal funds to purchase ESCs; it is nothing more than
another argument that the Guidelines could be applied unlawfully.
**
As the dissent notes, a panel of this court once held this standard
inapplicable to a facial statutory (as opposed to a facial
constitutional) challenge to a regulation. See Nat’l Mining Ass’n v.
U.S. Corps. of Eng’rs, 145 F.3d 1399, 1407-08 (D.C. Cir. 1998).
That decision, however, was made in the mistaken belief that the
Case: 10-5287 Document: 1305585 Filed: 04/29/2011 Page: 18
18
19
pass upon the plaintiffs’ argument they are likely to succeed
on their claim under the Administrative Procedure Act that
the NIH promulgated the Guidelines “through an inadequate
notice-and-comment process.”
20
As we see it, however, a preliminary injunction would in
fact upend the status quo. True, the plaintiffs compete with
ESC researchers for funding — indeed, that is why they have
standing to bring this case, see Sherley I, 610 F.3d at 71–74
— but they have been competing with ESC researchers since
2001. The 2009 Guidelines inflict some incremental handicap
upon the plaintiffs’ ability to compete for NIH money — they
point to the additional time and money they must expend and
have had to expend since 2001 to meet the additional
competition from researchers proposing to use ESCs — but it
is necessarily uncertain whether invalidating the Guidelines
would result in the plaintiffs getting any more grant money
from the NIH. Accordingly, we cannot say that, if the
plaintiffs are to litigate this case without the benefit of interim
relief, then the 2009 Guidelines will place a significant
additional burden upon their ability to secure funding for their
research.
21
using adult stem cells and why the plaintiffs’ “very
livelihood” instead depends upon obtaining grants from the
NIH.
III. Conclusion
2
Case: 10-5287 Document: 1305585 Filed: 04/29/2011 Page: 24
3
Case: 10-5287 Document: 1305585 Filed: 04/29/2011 Page: 25
Paul Fire & Marine Ins. Co., 566 F.3d 150, 158-59 (4th Cir.
2009) (describing “systematic” behavior as “a series of acts”
(internal quotation marks omitted)). The first sequence of hESC
research is the derivation of stem cells from the human embryo.
The derivation of stem cells destroys the embryo and therefore
cannot be federally funded, as the Government concedes. See
Maj. Op. at 14-15. I believe the succeeding sequences of hESC
research are likewise banned by the Amendment because, under
the plain meaning of “research,” they continue the “systematic
inquiry or investigation.”
That the intent of the 1996 Congress, in enacting the
Amendment, is to prohibit all hESC research—not just research
attendant on the derivation of the cells—is clear by comparing
the language used to ban federal funding for the creation of an
embryo with the language the plaintiffs rely on. See Erlenbaugh
v. United States, 409 U.S. 239, 244 (1972) (rule that statutes in
pari materia should be construed together “is but a logical
extension of the principle that individual sections of a single
statute should be construed together”); Motion Picture Ass’n of
Am. v. FCC, 309 F.3d 796, 801 (D.C. Cir. 2002) (“Statutory
provisions in pari materia normally are construed together to
discern their meaning.”). While the Amendment prohibits
federal financing of the “creation of a human embryo . . . for
research purposes,” it does not use parallel language in
addressing the destruction of embryos. It bans federal funding
of “research” rather than the “destruction of human embryos for
research purposes.” Research, then, is the express target of the
ban the Congress imposed with respect to the destruction of a
human embryo. This makes perfect sense because in 1996,
according to the record, hESC research had barely begun.
Deisher Decl. ¶ 7. The Congress, recognizing its scant
knowledge about the feasibility/scope of hESC research, chose
broad language with the plain intent to make the ban as complete
as possible. Because the meaning of research is plain, and the
4
Case: 10-5287 Document: 1305585 Filed: 04/29/2011 Page: 26
5
Case: 10-5287 Document: 1305585 Filed: 04/29/2011 Page: 27
1
That the Amendment references section 46.204(b) in comparing
the risk of injury or death to a human embryo does not affect the
Amendment’s incorporation of section 46.102(d)’s definition of
research. Determining the level of risk permitted for “research on
fetuses in utero under [section] 46.204(b)” necessarily requires
construing “research” and section 46.102(d) defines “research.”
6
Case: 10-5287 Document: 1305585 Filed: 04/29/2011 Page: 28
2
The Government may not have always taken this view of the
Amendment. See Letter from Kate Berg, Deputy Scientific Director,
NCHGR, to Wendy Fibison, Researcher at Georgetown University
Medical Center (Oct. 10, 1996) (Joint Appendix 283) (“NIH position
on embryo research” is federally funded researchers “[can]not engage
in embryo related research” including certain types of “analysis from
DNA derived from a human embryo”). But see Appellants’ Reply Br.
7-8 (claiming Georgetown research, like derivation, “require[d] the
removal of a cell from an embryo”).
3
The Government’s suggested change in inflection can fairly be
described as Clintonesque (“It depends upon what the meaning of the
word ‘is’ is.” H.R. Rep. No. 105-830, at 40 (Dec. 16, 1998) (quoting
Grand Jury Testimony of President W.J. Clinton, Jones v. Clinton,
No. 94-0290 (E.D. Ark. Apr. 12, 1999), at 57-58 (Aug. 17, 1998))).
7
Case: 10-5287 Document: 1305585 Filed: 04/29/2011 Page: 29
8
Case: 10-5287 Document: 1305585 Filed: 04/29/2011 Page: 30
4
Moreover, the Amendment combines the present tense “are”
with the past participle “destroyed,” that is, with “[a] verb form
indicating past or completed action or time that is used as a verbal
adjective.” Fla. Dep’t of Revenue v. Piccadilly Cafeterias, Inc., 554
U.S. 33, 39 (2008) (alteration in original) (quoting American Heritage
Dictionary 1287 (4th ed. 2000)). Other statutes similarly use the
present tense, especially a combination of “is” with a past participle,
to signify conduct that has already occurred. See, e.g., 10 U.S.C.
§ 6253 (Secretary of Navy “may replace . . . any medal of honor,
Navy cross[ etc.] awarded under this chapter that is stolen, lost, or
destroyed or becomes unfit for use” (emphases added), that is, a medal
which has been stolen, lost, or destroyed or become unfit for use
before replacement).
9
Case: 10-5287 Document: 1305585 Filed: 04/29/2011 Page: 31
5
Likewise, the sequenced action inherent in “research,” supra
pp. 3-4, does not equate to individual research “projects.”
6
Moreover, the challenged Guidelines were not promulgated
until 2009 so that congressional reenactment of the Amendment in the
years predating 2009 signifies nothing in relation to the Guidelines.
7
The majority opinion dismisses the plaintiffs’ challenge that the
Guidelines permit a researcher to use federal funds to purchase hESCs
and even permit a federally-funded researcher to derive the cells
10
Case: 10-5287 Document: 1305585 Filed: 04/29/2011 Page: 32
11
Case: 10-5287 Document: 1305585 Filed: 04/29/2011 Page: 33
613 F.3d 206, 213 (D.C. Cir. 2010) (applying Reno to facial challenge
of regulation without discussing Amfac or National Mining); Bldg. &
Constr. Trades Dep’t, AFL-CIO v. Allbaugh, 295 F.3d 28, 33 (D.C.
Cir. 2002) (possibility agency could improperly apply executive order
does not establish facial invalidity thereof). See generally Stuart
Buck, Salerno vs. Chevron: What to do About Statutory Challenges,
55 Admin. L. Rev. 427 (2003).
12
Case: 10-5287 Document: 1305585 Filed: 04/29/2011 Page: 34
13